📋 FDA Reference
Nexsite HD Hemodialysis Split Tip Catheter for Long Term Use 24cm Nexsite HD Hemodialysis Split Tip Catheter for Long Term Use 28cm Nexsite HD Hemodialysis Split Tip Catheter for Long Term Use 32cm Nexsite HD Hemodialysis Split Tip Catheter for Long Term Use 36cm Nexsite HD Hemodialysis Split Tip Catheter for Long Term Use 40cm Nexsite HD Hemodialysis Split Tip Catheter for Long Term Use 55cm
Summary: The NexSite HD Hemodialysis Catheter is a long-term dialysis access device used for hemodialysis in patients with chronic kidney disease. It is typically used by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K143567 ↗
Decision Date ?
March 31, 2015
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The NexSite HD Hemodialysis Catheter was cleared via the FDA 510(k) pathway on March 31, 2015. Manufactured by Marvao Medical Devices, it is classified as a Class 2 device under product code MSD.
What It Is
The NexSite HD Hemodialysis Catheter is a split tip catheter designed for long-term use in hemodialysis. It is inserted into a central vein, typically the internal jugular, to provide reliable vascular access for patients undergoing dialysis. The catheter is available in various lengths to accommodate different patient anatomies and is designed to optimize blood flow while minimizing complications.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis.
- Hemodialysis access for patients who require a central venous catheter.
- Use in patients with chronic kidney disease or kidney failure who need ongoing hemodialysis.
Clinical Applications
- Tunneled catheter placement for long-term hemodialysis access.
- Hemodialysis in patients who need central venous access.
- Dialysis access when an arteriovenous fistula or graft is not available, suitable, or ready for use.
Practical Considerations
- Available lengths include 24, 28, 32, 36, 40, and 55 cm; the appropriate length depends on patient anatomy and the selected venous access route.
- Placement and removal should be performed by trained clinicians using imaging guidance and sterile technique.
- The catheter must be connected to compatible hemodialysis equipment and securely managed to reduce risks of infection, thrombosis, malfunction, and dislodgement.
- MRI safety should be confirmed from the current manufacturer labeling and institutional device policy; the FDA record alone does not establish that this catheter is MRI safe or MRI conditional.
- The device is not a substitute for evaluation of an arteriovenous fistula or graft when those forms of dialysis access are appropriate.
Frequently Asked Questions
What is the NexSite HD Hemodialysis Catheter used for?
It is used for providing long-term vascular access for hemodialysis in patients with chronic kidney disease.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device, often in collaboration with interventional radiologists.
What are the FDA-cleared indications?
The device is indicated for patients requiring long-term hemodialysis access, particularly those with chronic kidney disease.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.